Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A study (Huntingdon Life Sciences, VHJ0047, 2013) was performed to assess the skin sensitization potential of MTF using the local

lymph node assay (LLNA). The study comprised three treated groups, each comprising four female mice receiving MTF

at concentrations of 10, 25 or 50% v/v.

Similarly constituted groups received the vehicle 4:1 v/v acetone: olive oil (AOO) or positive control substance (25% v/v hexyl cinnamic

aldehyde). The mice were treated by daily application of 25 µL of the appropriate concentration or control (vehicle or positive), to the dorsal surface of both ears for three consecutive days.

MTF was regarded as a potential skin sensitizer. The EC3ex value was calculated to be 8.3% v/v.

Migrated from Short description of key information:

The SI obtained for 10, 25 and 50% v/v was 3.8, 7.8, and 7.3 respectively which indicates that MTF showed the potential to induce skin sensitization.

The EC3ex value was calculated to be 8.3 % v/v.

Justification for classification or non-classification

As the EC3 value,obtained from the Local lymph node assay, was calculated to be > 2 % the MTF will be classified as a skin sensitiser Category 1B.